Erector Spinae Block for Spine Surgery

Lumbar Radiculopathy Clinical Trial

Official title:

Evaluation of the Addition of Liposomal Bupivacaine to the Erector Spinae Plane (ESP) Block to Multilevel Lumbar Spinal Fusion Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05417113
• Other study ID #: STUDY-22-00168
• Status: Terminated
• Phase: Phase 4
• Start date: August 31, 2022
• Est. completion date: February 27, 2024

Study information

• Verified date: May 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to determine whether or not the addition of liposomal bupivacaine in an ESP block will have long term benefits for patients undergoing lumbar spinal fusion surgery. Given previous studies found long term benefits from liposomal bupivacaine, the hypothesis is that patients will have decreased opioid usage and improved pain scores when compared to a standard ESP block with plain 0.25% bupivacaine.

Description:

This will be a double blind prospective randomized control trial comparing liposomal bupivacaine with plain bupivacaine in their effectiveness in ESP blocks in lumbar spinal fusion surgery. Patients scheduled for a lumbar spinal fusion procedure will be identified at the time of the scheduled surgery. The endpoints of this study include:

The primary objective is to compare the amount of postoperative intravenous opioid consumption among two study groups for the first 72 hours: Patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with liposomal bupivacaine + 0.25% bupivacaine and patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with 0.25% bupivacaine

The secondary objectives include:

Compare the severity of pain at rest at specific timepoints postoperatively. Compare general quality of recovery via QoR-15 at 48 hours, 72 hours and then at routine follow up visits occurring 2 weeks, 6 weeks, and 12 weeks postoperatively.

Measure rate of postoperative nausea/vomiting in PACU. Measure time to ambulation. Compare analgesia satisfaction score at time of discharge. Measure hospital length of stay.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: February 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion criteria:

• Adults aged greater than or equal to 18 years old and less than or equal to 85 years old.

• Patients who are scheduled to undergo lumbar spinal surgery (1-2 level) and willing and able to provide informed consent.

Exclusion criteria:

• Patients with a history of chronic opioid use for > 3 months including but not limited to fentanyl, morphine, oxycodone, methadone.

• Patients with known allergy or intolerance to any drug used in the study including local anesthetics and total intravenous anesthesia medications.

• Patients with a history of alcohol or drug abuse.

• Patients with a history of intolerance of nonsteroidal anti-inflammatory drugs.-Patients with hepatic insufficiency.

• Patients with renal insufficiency.

• Patients who are pregnant.

• Patients with American Society of Anesthesiologists physical status of 4 or greater.

• Patients on immunosuppressive therapy. Pregnant patients.

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

Intervention

Drug:
• Liposomal bupivacaine
liposomal bupivacaine
• Bupivacaine
bupivacaine 0.25% in ESP blocks

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Opioid Consumption During First 72 Hours	The amount of postoperative intravenous opioid consumption (Total morphine mg equivalents MME) during the first 72 hours	12 hours, 24 hours, 48 hours, 72 hours
Secondary	Change in Pain Score	Change in the severity of pain at rest using an 11-point Likert scale. Scale from 0-10, with higher score indicating more pain.	up to 12 weeks
Secondary	Quality of Recovery (QOR 15)	Change in general quality of recovery using a 15 point questionnaire via QoR-15 with regard to how the patient is feeling scored on a scale from 0-10, with 0 being none of the time and 10 being all of the time. Full scale range from 0-150, with a higher score indicating a better health outcome.	72 hours
Secondary	Number of Participants With Postoperative Nausea/Vomiting (PONV)	Number of participants with postoperative nausea/vomiting (PONV) in PACU	in PACU (4 hours)
Secondary	Time to Ambulation	Time to ambulation in hours	average 26-27 hours
Secondary	Hospital Length of Stay	Hospital length of stay (LOS)	average 72 hours